WARNINGS: SUICIDALITY AND ANTIDEPRESSANT DRUGS
Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of Lexapro or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Lexapro is not approved for use in pediatric patients less than 12 years of age.
[See Warnings and Precautions: Clinical Worsening and Suicide Risk Patient Counseling Information: Information for Patients (17.1), and Used in Specific Populations: Pediatric Use].
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LEXAPRO SUMMARY
Lexapro® (escitalopram oxalate) is an orally administered selective serotonin reuptake inhibitor (SSRI). Escitalopram is the pure S-enantiomer (single isomer) of the racemic bicyclic phthalane derivative citalopram.
Major Depressive Disorder
Lexapro (escitalopram) is indicated for the acute and maintenance treatment of major depressive disorder in adults and in adolescents 12 to 17 years of age [ see Clinical Studies (14.1) ].
A major depressive episode (DSM-IV) implies a prominent and relatively persistent (nearly every day for at least 2 weeks) depressed or dysphoric mood that usually interferes with daily functioning, and includes at least five of the following nine symptoms: depressed mood, loss of interest in usual activities, significant change in weight and/or appetite, insomnia or hypersomnia, psychomotor agitation or retardation, increased fatigue, feelings of guilt or worthlessness, slowed thinking or impaired concentration, a suicide attempt or suicidal ideation.
Generalized Anxiety Disorder
Lexapro is indicated for the acute treatment of Generalized Anxiety Disorder (GAD) in adults [ see Clinical Studies (14.2) ].
Generalized Anxiety Disorder (DSM-IV) is characterized by excessive anxiety and worry (apprehensive expectation) that is persistent for at least 6 months and which the person finds difficult to control. It must be associated with at least 3 of the following symptoms: restlessness or feeling keyed up or on edge, being easily fatigued, difficulty concentrating or mind going blank, irritability, muscle tension, and sleep disturbance.
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NEWS HIGHLIGHTS
Published Studies Related to Lexapro (Escitalopram)
Escitalopram treatment for depressive disorder following acute coronary syndrome:
a 24-week double-blind, placebo-controlled trial. [2015]
CONCLUSIONS: These results indicate that escitalopram has clinically meaningful
A double-blind, randomized, placebo-controlled clinical trial of
S-adenosyl-L-methionine (SAMe) versus escitalopram in major depressive disorder. [2014]
CONCLUSIONS: The results fail to support an advantage over placebo for either the
Citalopram and escitalopram in the treatment of major depressive disorder: a
pooled analysis of 3 clinical trials. [2014]
disorder (MDD) using pooled analyses... CONCLUSIONS: The pooled analysis showed that over a 6-week treatment period,
Effects of escitalopram on markers of bone turnover: a randomized clinical trial. [2014]
CONCLUSIONS: Although the study was limited to 8 weeks, these results suggest
Impact of escitalopram on vagally mediated cardiovascular function in healthy
participants: implications for understanding differential age-related, treatment
emergent effects. [2014]
determine whether age moderates these effects... CONCLUSIONS: Maturational differences in the development of the prefrontal
Clinical Trials Related to Lexapro (Escitalopram)
Brain Effects of Escitalopram and Citalopram Using fMRI [Completed]
Escitalopram (Lexapro) and citalopram (Celexa) are similar selective serotonin reuptake
inhibitors that alter blood flow to the amygdala and other brain structures involved in
regulating mood. Escitalopram consists of S-citalopram while citalopram contains both
S-citalopram and R-citalopram (racemic citalopram). There is evidence that R-citalopram may
block the effects of S-citalopram. The hypothesis being tested is that because of the
antagonist effect of R-citalopram, S-citalopram will have a greater effect on the mood
circuit than racemic citalopram when equal doses of S-citalopram are administered. The study
design consists of a two week medication period followed by blood oxygen level dependent
(BOLD) functional magnetic resonance imaging (fMRI) while viewing affective visual stimuli.
An Efficacy and Safety Study of Escitalopram Long-Term Treatment in Major Depressive Disorder With Associated Anxiety Symptoms [Completed]
The purpose of this study is to evaluate the efficacy and safety of long term escitalopram
treatment in participants with Major Depressive Disorder (MDD) with associated anxiety
symptoms.
Lexapro�'s Efficacy After Dose Escalation in Remission Study [Recruiting]
The purpose of this study is the evaluation of remission rate between escitalopram 20 mg and
30 mg in patients with major depressive disorder.
Escitalopram (Lexapro) for Depression MS or ALS [Completed]
The purpose of this study is to see if escitalopram (Lexapro) improves symptoms of major
depressive disorder in patients who have ALS or MS.
EScitalopram PIndolol ONset of Action [Terminated]
The main purpose of this study is to determine whether the antidepressant response of
escitalopram 30mg/day or escitalopram 20mg/day + pindolol, a beta blocker, is different
(faster) compared to a standard dose of escitalopram 20mg/day.
Reports of Suspected Lexapro (Escitalopram) Side Effects
Drug Ineffective (61),
Suicidal Ideation (57),
Depression (56),
Nausea (56),
Anxiety (49),
Insomnia (47),
Maternal Drugs Affecting Foetus (39),
Weight Increased (38),
Headache (37),
Feeling Abnormal (35), more >>
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 74 ratings/reviews, Lexapro has an overall score of 6.89. The effectiveness score is 7.46 and the side effect score is 7.30. The scores are on ten point scale: 10 - best, 1 - worst. Below are selected reviews: the highest, the median and the lowest rated.
| | Lexapro review by 36 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | depression/anxiety |
| Dosage & duration: | | 10mg daily taken daily for the period of two months and continuingto use it |
| Other conditions: | | frustrated/short temper/mood swings |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | better outlook on life in general, less anxious, easier to deal with everything, a difference of night and day |
| Side effects: | | during the initial dose(first week to ten days) a bit of nausea,strange sensation in teeth and my head felt a little odd |
| Comments: | | I am happily married with two children, ages three and five. For years I cried everyday, freaked out at the drop of a hat, yelled all the time, had no self esteem and sometimes thought I could not go on. After two weeks of taking Lexapro I am a completely different person. I have not cried once after the first week of being treated. I love myself and my kids. All the menial tasks that I felt so difficult before, I now do with a great sense of ease. My friends and family notice a huge change in me. I couldn't be happier. |
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| | Lexapro review by 46 year old female patient | | | Rating |
| Overall rating: | |  |
| Effectiveness: | | Highly Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | anxiety and depression |
| Dosage & duration: | | 10mg taken daily for the period of 2 years |
| Other conditions: | | going through menopause |
| Other drugs taken: | | none | | |
Reported Results |
| Benefits: | | After the first few DAYS my anxiety was greatly reduced. I felt less depressed and did not feel prone to panic attacks that I had been having prior to starting this medication. I was very pleased with the reduced anxiety and depression. |
| Side effects: | | At first I had some mild nausea, which went away and then I didn't have any side effects. This medication did not make me gain weight and it did not lower my sex drive- both which were concerns for me. |
| Comments: | | The medication worked great, and I would have rated it a 10 except getting OFF the medication was difficult. For six-eight weeks I had what I've come to learn are called brain zaps... a strange sensation that is difficult to describe and not pleasant. Lucky for me I had read about this so it did not scare me... otherwise I would have been very concerned. I pretty much just rode it out for those 6-8 weeks and then it went away and I've been fine. If I had to do it over I would still have chosen to take the lexapro because is was so effective for my anxiey/depression which was off the charts when I started. |
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| | Lexapro review by 29 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Ineffective |
| Side effects: | | Extremely Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | depression |
| Dosage & duration: | | 10mg taken once a month for the period of 2 days |
| Other conditions: | | biploar |
| Other drugs taken: | | lithum | | |
Reported Results |
| Benefits: | | It was suspose to help ease my depression issues that happend when the biploar side of me was not in hyper. It was a new drug it was suspose to be very effeect. Not cause any weight gain. With very little side effects. |
| Side effects: | | I had very bads nightmares for about two nights. The nightmare wre of me hurting my family. I could see myself killing my family it seemed so very real to me I have never experienced any thing like that before in my life. I told my husband to stay up and please watch me to make sure do not do any thing.So I did not take them any more |
| Comments: | | I was to take one 10mg pill at night before I go to bed every night. It did not matter if it was taken with food or with out food. Either way was fine. I had to take it at the same time every night. I was not suspose ot stop treatment unless my doctor said it was ok. |
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Page last updated: 2015-08-10
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